A Prospective, Multicenter Trial of the VentrAssist Left Ventricular Assist Device for Bridge to Transplant: Safety and Efficacy

Donald Esmore, David Kaye, Phillip Spratt, Robert Larbalestier, Peter Ruygrok, Steven Tsui, Deborah Meyers, Arnt E. Fiane, John Woodard

Research output: Contribution to journalArticlepeer-review

70 Scopus citations

Abstract

Background: The increasing prevalence of chronic heart failure has stimulated the ongoing development of left ventricular assist devices (LVADs) for both bridge-to-transplant (BTT) and destination therapy (DT). The aim of this prospective, multicenter clinical trial was to determine the efficacy and safety of a third-generation LVAD, the VentrAssist, in a BTT cohort. Methods: Patients (n = 33) with end-stage chronic heart failure who required circulatory support as BTT therapy were implanted with a VentrAssist device. The primary outcome was survival until transplant or transplant eligibility with the device in situ at trial end-point (Day 154 after implant). The secondary outcomes were pump flow index and end-organ function. Safety, patient functional status and resource use were also assessed. Results: At trial end-point, the success rate was 82% (39.4% transplanted, 42.4% transplant-eligible). The LVAD pump flow index (median ≥2.7 liters/min/m2) was sufficient to maintain an adequate circulation and significantly improve end-organ function. Of the 77 protocol-defined serious adverse events, most occurred within 30 days of implantation. No patients died as a direct result of pump failure or malfunction. After implantation, patient functional status improved, with 70% of patients achieving hospital discharge, and resource use was reduced. Conclusions: This trial demonstrated a favorable efficacy and safety profile for use of the VentrAssist LVAD in BTT patients.

Original languageEnglish (US)
Pages (from-to)579-588
Number of pages10
JournalJournal of Heart and Lung Transplantation
Volume27
Issue number6
DOIs
StatePublished - Jun 2008
Externally publishedYes

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine
  • Transplantation

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